Reporting quality of heart failure randomized controlled trials 2000-2020: Temporal trends in adherence to CONSORT criteria.

AIM: Heart failure (HF) is a major cause of morbidity and mortality in older adults. Randomized controlled trials (RCTs) inform HF policy and practice, but the accurate interpretation of results is contingent on clear and transparent reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement serves as a guide to RCT reporting. We evaluated the quality of reporting in HF RCTs in high-impact journals by assessing their adherence to CONSORT. METHODS AND RESULTS: We searched MEDLINE, EMBASE and CINAHL for HF RCTs published in high-impact journals 2000-2020. We assessed the proportion of CONSORT criteria that individual HF RCTs adhered to, and used the Jonckheere-Terpstra test to examine temporal trends in adherence. Multivariable linear regression explored the association between trial characteristics and adherence to CONSORT. Primary analysis assessed adherence to CONSORT 2010 update. A sensitivity analysis assessed adherence to the original (1996) CONSORT criteria. Among 221 RCTs analysed, the mean (standard deviation [SD]) adherence was suboptimal overall (mean [SD] adherence 69.7 [11.5]%) (5513/7913 criteria), with a temporal increase in adherence over the 20-year period (p < 0.001). Factors associated with adherence included publication after versus during/before 2010 (ß = 10.17, 95% confidence interval [CI] 7.64-12.70; p < 0.001); two-group parallel individual-level randomization versus other (including multi-group or cluster randomization) (ß = 5.81, 95% CI 2.88-8.73; p < 0.001); and multicentre versus single-centre trials (ß = 7.26, 95% CI 3.25-11.27; p < 0.001). There was no difference in trial adherence to the updated CONSORT (2010) versus the original (1996) CONSORT criteria, and temporal trends in adherence to both sets of criteria were similar, likely due to overlap between the two sets of criteria. Trials with greater adherence to CONSORT were published in higher impact factor journals, with a positive correlation (r = 0.312; p < 0.001). CONCLUSION: The quality of reporting in HF RCTs, as measured by CONSORT adherence, has improved over time but remains suboptimal.

Justification for unequal allocation ratios in clinical trials: A scoping review.

OBJECTIVE: The objective of this review is to provide an overview of the justification reported for using unequal allocation ratios in randomized clinical trials (RCTs) testing a medical intervention. METHODS: Using the PICOS framework, we conducted a systematic search to find meta-studies within PubMed (a Medline database interface) that addressed the objective. RESULTS: The developed search strategy generated 525 results, of which, three studies met criteria for inclusion. These studies found that 22-43% of RCTs provided a justification for the use of unequal allocation based on publication alone, and between 38.7 and 66% after seeking input from trial authors. The most common reason given for this design was to gather increased safety data according to two reviews and to gain experience with an intervention according to the third review. CONCLUSION: Reporting of justification for RCTs designed with unequal allocation appears to occur less than half the time in the included studies. The reasons given for designing clinical trials with unequal participants encompass many domains, including ethical considerations. As such, this design feature should be implemented with intentionality to maximize the ethical features of clinical trials for participants. Coupling lack of justification with lack of adjusting for sample size estimations depicts an overall landscape in which there is significant room for improvement in methodological transparency within this area of RCTs.

Evaluation of quality of abstracts of randomized controlled trials on procedural sedation in children after publication of CONSORT guidelines for abstracts: A systematic review.

The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for abstracts of randomized controlled trials (RCTs). This study was done to assess the reporting quality of abstracts of RCTs, on procedural sedation in children and identify factors associated with better quality. A PubMed search was conducted from inception of database till July 2017 to identify RCTs on procedural sedation in children. Search terms used were (procedural [All Fields] AND sedation [All Fields]) AND ("child" [MeSH Terms] OR "child" [All Fields] OR "children" [All Fields]) were included in the analysis, while primary RCTs, published in the English language unstructured abstracts, secondary analysis of primary RCTs and studies not exclusively on children we excluded. Our search strategy initially yielded 582 abstracts. Out of these, 535 abstracts were excluded. 47 articles were included in the final analysis. We extracted basic information and data on CONSORT items from abstracts. Each abstract was assessed using a 16-item composite abstract score (CAS) based on the CONSORT guidelines. This abstract quality was further explored by Method Score and by Result Score. Regression analysis was conducted to analyze factors associated with reporting quality. In majority of the abstracts, only objectives and conclusion were adequately reported. Inadequately reported items in >90% of abstracts included randomization, trial status, registration & funding. There was no significant difference in the CAS of abstracts (mean ± SD) published in & before 2008 (12.63 ± 4.0), to those published after 2009 (12.48 ± 4.23). Similarly, there was no significant difference in Result Score and Method Score of the abstracts. After the publication of 'CONSORT for abstracts' guideline, the quality of abstracts of RCTs on procedural sedation has shown suboptimal improvement. We suggest stricter adherence to guidelines by editors and reviewers. A checklist for adherence to CONSORT guidelines could be introduced during submission for the same.

MAN v FAT Soccer: Feasibility Study and Preliminary Efficacy of a Sport-Based Weight-Loss Intervention for Overweight and Obese Men in Australia.

MAN v FAT Soccer is a sport-based weight-loss program for overweight and obese men that originated in the United Kingdom (i.e., as MAN v FAT Football) and appears to successfully engage men with weight loss. We sought to explore whether the program would work in an Australian context by (a) establishing a foundation for the implementation of the program on a larger scale and (b) determining how large-scale implementation is most feasible. We conducted a nonrandomized, single intervention group feasibility trial of MAN v FAT Soccer in Australia with 418 male participants with a body mass index greater than 27.50 kg/m2. Results indicate that the program is acceptable, with participants reporting positive perceptions of the various components of the program and a high proportion reporting intentions to recommend the program to others (95.9%). Furthermore, preliminary effectiveness results indicate positive changes in weight (4.6% reduction) and physical activity (88.5% increase) and improvements in psychological outcomes such as depression (17.6% decrease), stress (19.0% decrease), and body appreciation (19.1% increase). Our findings provide general support for the feasibility of MAN v FAT Soccer and the notion that leveraging competition and masculinity may help drive men's health behavior change.

The reporting quality of N-of-1 trials and protocols still needs improvement.

OBJECTIVE: To evaluate the reporting quality of single-patient (N-of-1) trials and protocols based on the CONSORT Extension for N-of-1 trials (CENT) statement and the standard protocol items: recommendations for interventional trials (SPIRIT) extension and elaboration for N-of-1 trials (SPENT) checklist to examine the factors that influenced reporting quality. METHODS: Four electronic databases were searched to identify N-of-1 trials and protocols from 2015 to 2020. Quality was assessed by two reviewers. We calculated the overall scores based on binary responses in which "Yes" was scored as 1 (if the item was fully reported), and "No" was scored as 0 (if the item was not clearly reported or not definitely stated). RESULTS: A total of 78 publications (55 N-of-1 trials and 23 protocols) were identified. The mean reporting score (SD) of the N-of-1 trials and protocols were 29.24 (0.89) and 29.61 (1.83), respectively. For the items related to outcomes, sample size, allocation concealment protocol, and informed consent materials, the reporting quality was low. Our results showed that the year of publication (t = -0.793, p = 0.872 for the trials and t = 1.352, p = 0.623 for the protocols) and the impact factor of the journal (t = 1.416, p = 0.619 for the trials and t = 0.359, p = 0.667 for the protocols) were not factors associated with better reporting quality. CONCLUSION: With the publication of the CENT 2015 statement and the SPENT 2019 checklist, authors should adhere to the relevant reporting guidelines and improve the reporting quality of N-of-1 trials and protocols.

Quality of reporting for pilot randomized controlled trials in the pediatric urology literature-A systematic review.

BACKGROUND: The conduct and reporting of pilot studies is important to assess the feasibility of future randomized controlled trials (RCT). The Consolidated Standards of Reporting Trials (CONSORT) statement extension to pilot/feasibility studies addresses the reporting quality of the pilot studies (Summary Table 1). The aims of this systematic review are (1) to assess the reporting quality of pilot studies in pediatric urology and (2) to explore the factors that are associated with the reporting quality of these studies. METHODS: A comprehensive search was conducted through MEDLINE® and EMBASE® to identify pilot RCTs from 2005 to 2018. Two reviewers independently performed title and abstract screening and full text review, with discrepancies resolved by consensus. CONSORT extension reported items were summarized and overall proportion of reported items for each article was estimated. A linear regression model was conducted to determine factors associated with higher reporting quality. Publication year, biostatistician/epidemiologist support, sample size justification and journal impact factor were collected. RESULTS: Of the 1463 titles duplicates were removed and 1347 were screened, 36 studies were included. Overall, 36 pilot studies reported about 8-9 of 17 items [51% (95% CI: 46 - 56%)]. The most reported items were contact details for the corresponding author (97%), title identification of study as randomised pilot or feasibility trial (95%), eligibility criteria and setting (81%), both interventions (78%), and specific objectives of the pilot trial (75%). Less fulfilled items were blinding (11%), registration of the trial (11%), randomization details (28%), detailing recruitment status in the pilot study (19%), trial design (31%), and source of funding for pilot trial (34%). Interpretation of the results of pilot trial and their implications for the future definitive trial was reported by 34% of the studies. Factors associated with higher reporting quality were the presence of biostatistician or epidemiologist (P = 0.004), and if the sample size for the pilot study was justified (P = 0.002). DISCUSSION: Overall reporting quality of pilot studies in pediatric urology literature from 2005-2018 was suboptimal. The quality of pilot RCTs included in the present review were lower than that observed in the orthopedic literature, however, it appears to be consistent with the trends regarding OQS in chronic kidney disease and allopathic medicine. While we endeavoured to maintain utmost rigidity of this systematic review, there are inherent limitations. The CONSORT 2010 extension for pilot RCTs was published in 2016. Clinical trials can take several years, many pilot studies published pre-2016 would not have had the guidance of the extension during designing phases. Not all pilot RCTs are published, so this could potentially reduce the generalizability of the findings from this review. Only studies in English, published in full peer-reviewed journals were included, and this review only addressed the reporting quality of pilot studies in pediatric urology. CONCLUSION: This review demonstrated that reporting quality of pilot studies in pediatric urology is currently suboptimal. Including biostatistician and/or epidemiologist, can ameliorate the quality of future pilot studies. Implementing CONSORT 2010 extension by journals as a prerequisite for submission of pilot or feasibility trials is recommended to improve the robustness and transparency of future pilot studies.

Quality criteria for randomized controlled studies: obstetrical journal guidelines.

BACKGROUND: Most retractions of obstetrics and gynecology manuscripts are because of scientific misconduct. It would be preferable to prevent randomized controlled trials with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later. OBJECTIVE: This study aimed to evaluate the policies of obstetrics and gynecology and top medical journals in their author guidelines and electronic submission systems regarding prospective randomized controlled trial registration, ethics committee approval, research protocols, Consolidated Standards of Reporting Trial guidelines, and data sharing and to detect the most common quality criteria requested for randomized controlled trials in these journals. STUDY DESIGN: Author guidelines were identified via online Google searches from the websites of selected peer-reviewed medical journals. Journals in obstetrics and gynecology were selected from the list of journals with impact factors based on the Journal Citation Report released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular randomized controlled trials. In addition, 4 of the top impact factor peer-reviewed general medical journals publishing randomized controlled trials were included. The requirements for selected quality criteria for randomized controlled trials analyzed in the author guidelines for each journal were details of 5 general issues: prospective randomized controlled trial registration (4 subcategories), ethics committee approval (4 subcategories), research protocol (3 subcategories), Consolidated Standards of Reporting Trials guidelines (3 subcategories), and data sharing (3 subcategories). To evaluate the requirements within the electronic submission system, a mock submission of a randomized controlled trial was also done for each journal, and the same criteria were assessed on the online software for submission. The primary outcome was the overall percentage for each of the quality criteria that were listed as required within the author guidelines or required in the submission system among all journals. Planned subgroup analyses were top general medicine vs obstetrics and gynecology journals and top 4 obstetrics and gynecology vs other obstetrics and gynecology journals. RESULTS: Most studied peer-reviewed journals listed in their author guidelines 7 specific criteria for submission of randomized controlled trials: prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement. For most journals, the submission software did not require these or any other criteria for submission. There were minimal differences in criteria listed for top medical journals vs other obstetrics and gynecology journals and among top vs other obstetrics and gynecology journals. CONCLUSION: Prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement are the randomized controlled trial quality criteria requested by leading medical and obstetrics and gynecology journals. These obstetrics and gynecology journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines and also through improved submission software.

Systematic review on the reporting quality of randomized controlled trials in patients with hepatitis B or C in China.

BACKGROUND: The numbers of articles reporting randomized controlled trials (RCTs) on viral hepatitis in China have been increasing, but there have been few systematic studies evaluating the reporting quality of RCTs in this field. This study was performed to assess the reporting quality of RCTs on the treatment of hepatitis B and C in China from 1991 to 2015. METHODS: Articles published between January 1991 and December 2015 were identified via the PubMed, MEDLINE, and Embase databases using the key words "randomized clinical trials", "treatment", "therapy", "hepatitis B", "HBV", "hepatitis C", "HCV", "China", and "Chinese". The reporting quality was assessed against the Consolidated Standards of Reporting Trials (CONSORT) checklist. RESULTS: In total, 211 RCTs on the treatment of hepatitis B or C were included. The number of articles focusing on these RCTs increased rapidly over time, while the reporting quality improved steadily over time. Overall, compliance with the key components of the CONSORT checklist was low, with only 8.5%, 3.8%, and 11.4% of the articles fulfilling the reporting requirements of randomization, allocation concealment, and blinding, respectively. CONCLUSIONS: Both the number and the quality of RCT articles were found to have increased steadily over the last two decades. However, compliance with the key components of the CONSORT checklist still needs improvement. It is hoped that the results of this study will lead to improvements in the reporting quality of clinical trials on hepatitis B and C in China.

Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals.

Background: In articles reporting randomized controlled trials, professional medical writing support is associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT). We set out to determine whether professional medical writing support was also associated with improved adherence to CONSORT for Abstracts. Methods: Using data from a previously published cross-sectional study of 463 articles reporting randomized controlled trials published between 2011 and 2014 in five top medical journals, we determined the association between professional medical writing support and CONSORT for Abstracts items using a Wilcoxon rank-sum test. Results: The mean proportion of adherence to CONSORT for Abstracts items reported was similar with and without professional medical writing support (64.3% vs 66.5%, respectively; p=0.30). Professional medical writing support was associated with lower adherence to reporting study setting (relative risk [RR]; 0.40; 95% confidence interval [CI], 0.23-0.70), and higher adherence to disclosing harms/side effects (RR 2.04; 95% CI, 1.37-3.03) and funding source (RR 1.75; 95% CI, 1.18-2.60). Conclusions: Although professional medical writing support was not associated with increased overall adherence to CONSORT for Abstracts, important aspects were improved with professional medical writing support, including reporting of adverse events and funding source. This study identifies areas to consider for improvement.

Reporting quality of N-of-1 trials published between 1985 and 2013: a systematic review.

OBJECTIVES: To evaluate the quality of reporting of single-patient (N-of-1) trials published in the medical literature based on the CONSORT Extension for N-of-1 Trials (CENT) statement and to examine factors that influence reporting quality in these trials. STUDY DESIGN AND SETTING: Through a search of 10 electronic databases, we identified N-of-1 trials in clinical medicine published between January 1, 1985, and December 31, 2013. Two reviewers screened articles for eligibility and independently extracted data. Quality assessment was performed using the CENT statement. Discrepancies were resolved by consensus. RESULTS: We identified 112 eligible N-of-1 trials published in 87 journals and involving a total of 2,278 patients. Overall, kappa agreement between the two evaluators for compliance with CENT criteria was 0.80 (95% confidence interval: 0.79, 0.82). Trials assessed pharmacology and therapeutics (87%), behavior (11%), or diagnosis (2%). Although 87% of articles described the trial design (including the planned number of subjects and length of treatment period), the median percentage of specific CENT elements reported in the Methods was 41% (range, 16-87%), and the median percentage in the Results was 38% (range, 32-93%). First authors were predominantly from North America (46%), Europe (29%), and Australia (17%). Quality of reporting was higher in articles published in journals with relatively high-impact factors (P = 0.004). CONCLUSION: The quality of reporting of published N-of-1 trials is variable and in need of improvement. Because the CENT guidelines were not published until near the end of the period of this review, these results represent a baseline from which improvement may be expected in the future.

Transparency in the reporting of in vivo pre-clinical pain research: The relevance and implications of the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines.

Clear reporting of research is crucial to the scientific process. Poorly designed and reported studies are damaging not only to the efforts of individual researchers, but also to science as a whole. Standardised reporting methods, such as those already established for reporting randomised clinical trials, have led to improved study design and facilitated the processes of clinical systematic review and meta-analysis. Such standards were lacking in the pre-clinical field until the development of the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines. These were prompted following a survey which highlighted a widespread lack of robust and consistent reporting of pre-clinical in vivo research, with reports frequently omitting basic information required for study replication and quality assessment. The resulting twenty item checklist in ARRIVE covers all aspects of experimental design with particular emphasis on bias reduction and methodological transparency. Influential publishers and research funders have already adopted ARRIVE. Further dissemination and acknowledgement of the importance of these guidelines is vital to their widespread implementation. Conclusions and implications Wide implementation of the ARRIVE guidelines for reporting of in vivo preclinical research, especially pain research, are essential for a much needed increased transparency and quality in publishing such research. ARRIVE will also positively influence improvements in experimental design and quality, assist the conduct of accurate replication studies of important new findings and facilitate meta-analyses of preclinical research.